Job Overview:
The QA Associate Director, APAC ex-India serves as a strategic regional RC&QA solutions partner, providing line management and day-to-day quality leadership across APAC ex-India. The role reports to the designated regional RC&QA leader and executes regional RC&QA strategy and priorities established by regional leadership, translating strategic objectives, business priorities, client expectations, country-specific requirements, and global quality strategy into operational quality solutions, team priorities, stakeholder engagement plans, and measurable outcomes.
The primary focus is execution of regional RC&QA priorities, day-to-day regional quality leadership, stakeholder engagement, client and country support, quality intelligence, risk management, region-specific quality issues, capability building, and continuous improvement. Global AIM retains ownership of audit and inspection execution processes, logistics, and administrative workflow, while the Associate Director provides regional expertise, stakeholder engagement, country support, SME leadership, and coordination or execution of selected activities based on risk, business need, language requirements, and resource availability.
The role acts as a senior regional technical SME and a constructive interface between operations, clients, country teams, and global quality functions. It brings forward regional intelligence and recommendations while supporting sustainable team delivery. Professional fluency in English and Mandarin Chinese is required to provide effective support for regional stakeholders and Chinese-language activities.
Summary of Responsibilities:
Execute regional RC&QA strategy and priorities established by regional leadership, providing day-to-day quality leadership, line management, and practical, independent, risk-based regulatory and compliance advice across APAC ex-India. Translate business priorities, quality risks, client expectations, country requirements, local operating practices, and cultural considerations into clear team objectives, resource decisions, stakeholder engagement plans, and measurable outcomes.
Serve as the primary RC&QA subject matter expert for APAC ex-India, providing interpretation of regulations, quality strategy, inspection intelligence, quality issue governance, escalation support, and consultation on complex compliance matters.
Develop and maintain strategic partnerships with country leadership, regional operations leaders, and client delivery teams to identify emerging risks, incorporate quality considerations into business decisions, and provide coordinated support to country and client-facing teams.
Support regional business development and growth by contributing quality strategy, regulatory insight, inspection intelligence, risk assessments, quality narratives, and technical expertise for proposals, due diligence, bid defenses, sponsor qualification activities, and client discussions.
Represent APAC ex-India RC&QA in regional and global quality forums, sponsor governance meetings, quality reviews, inspection-readiness activities, client engagements, and business decision-making, ensuring regional risks, country and client considerations, and recommended actions are visible to appropriate stakeholders.
Lead regional quality intelligence and coordinate Quality Management Review inputs by integrating meaningful metrics, audit outcomes, inspection intelligence, quality trends, recurring issues, CAPA themes, stakeholder feedback, risk assessments, and inspection-readiness updates into actionable management insights and improvement priorities.
Provide RC&QA leadership for significant regional quality events, client escalations, protocol compliance concerns, regulatory reportability assessments, inspection findings, and issues with potential participant safety, trial integrity, or data integrity implications. Facilitate appropriate investigation, impact assessment, root-cause analysis, CAPA, escalation, and resolution…